Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

OMB 0910-0233

This information collection supports regulations in 21 CFR part 60 pertaining to patent term restoration and the submission of requests for revision of the regulatory review period under 21 CFR 60.25; due diligence petitions under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40.

The latest form for Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions expires 2023-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0233 SSA 01.04.2023_Clean.docx Supporting Statement A
Revision of Regulatory Review Period Determinations
Due diligence hearings
Due diligence petitions

All Historical Document Collections

202207-0910-003 Approved without change	Extension without change of a currently approved collection	2023-03-30
202004-0910-006 Approved without change	Extension without change of a currently approved collection	2020-04-27
201704-0910-002 Approved without change	Extension without change of a currently approved collection	2017-04-25
201402-0910-004 Approved without change	Extension without change of a currently approved collection	2014-02-19
201101-0910-006 Approved without change	Extension without change of a currently approved collection	2011-01-18
200711-0910-005 Approved without change	Extension without change of a currently approved collection	2007-11-20
200409-0910-002 Approved without change	Extension without change of a currently approved collection	2004-09-10
200108-0910-003 Approved without change	Extension without change of a currently approved collection	2001-08-15
199808-0910-002 Approved without change	Extension without change of a currently approved collection	1998-08-12
199502-0910-001 Approved without change	Extension without change of a currently approved collection	1995-02-07
199110-0910-001 Approved without change	Revision of a currently approved collection	1991-10-02
198905-0910-020 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-05-24
198905-0910-016 Approved with change	No material or nonsubstantive change to a currently approved collection	1989-05-05
198809-0910-002 Approved without change	Revision of a currently approved collection	1988-09-21
198610-0910-007 Approved without change	New collection (Request for a new OMB Control Number)	1986-10-08

OMB Details

Revision of Regulatory Review Period Determinations

Federal Enterprise Architecture: Health - Consumer Health and Safety